CA2495678A1 - Apparatus and method for diagnostic gas analysis - Google Patents

Apparatus and method for diagnostic gas analysis Download PDF

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Publication number
CA2495678A1
CA2495678A1 CA002495678A CA2495678A CA2495678A1 CA 2495678 A1 CA2495678 A1 CA 2495678A1 CA 002495678 A CA002495678 A CA 002495678A CA 2495678 A CA2495678 A CA 2495678A CA 2495678 A1 CA2495678 A1 CA 2495678A1
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CA
Canada
Prior art keywords
sensor
patient
sample
flow rate
exhalation
Prior art date
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Granted
Application number
CA002495678A
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French (fr)
Other versions
CA2495678C (en
Inventor
Pontus Von Bahr
Tryggve Hemmingsson
Anders Jakobsson
Fredrik Gustafsson
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Circassia AB
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Individual
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Priority claimed from SE0202742A external-priority patent/SE0202742D0/en
Priority claimed from SE0202906A external-priority patent/SE0202906D0/en
Application filed by Individual filed Critical Individual
Publication of CA2495678A1 publication Critical patent/CA2495678A1/en
Application granted granted Critical
Publication of CA2495678C publication Critical patent/CA2495678C/en
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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0803Recording apparatus specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/082Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/097Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/486Bio-feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/7405Details of notification to user or communication with user or patient ; user input means using sound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/742Details of notification to user or communication with user or patient ; user input means using visual displays
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/22Devices for withdrawing samples in the gaseous state
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/76Chemiluminescence; Bioluminescence
    • G01N21/766Chemiluminescence; Bioluminescence of gases
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/0004Gaseous mixtures, e.g. polluted air
    • G01N33/0009General constructional details of gas analysers, e.g. portable test equipment
    • G01N33/0027General constructional details of gas analysers, e.g. portable test equipment concerning the detector
    • G01N33/0036Specially adapted to detect a particular component
    • G01N33/0037Specially adapted to detect a particular component for NOx
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/497Physical analysis of biological material of gaseous biological material, e.g. breath
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/0004Gaseous mixtures, e.g. polluted air
    • G01N33/0009General constructional details of gas analysers, e.g. portable test equipment
    • G01N33/0011Sample conditioning
    • G01N33/0016Sample conditioning by regulating a physical variable, e.g. pressure, temperature
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/20Air quality improvement or preservation, e.g. vehicle emission control or emission reduction by using catalytic converters
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/17Nitrogen containing
    • Y10T436/177692Oxides of nitrogen
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/17Nitrogen containing
    • Y10T436/177692Oxides of nitrogen
    • Y10T436/179228Both nitrogen oxide and dioxide
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/25Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/25375Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

The invention concerns a handheld, small but accurate and reliable device for diagnostic NO measurements using a NO sensor, where the parameters governing the taking of the sample are different from the parameters optimal for the accuracy of said NO sensor. By temporarily storing a portion of the exhaled air, and feeding this to the sensor at a flow rate adapted to the NO sensor, the accuracy and sensitivity of a system / method involving NO sensors, in particular electrochemical NO sensors, can be increased. The method for diagnostic NO measurements comprises steps for controlling the inhalation of NO free air, as well as the exhalation, both by built-in means and by audible and/or visual feedback to the patient.

Claims (29)

1. Device for diagnostic NO measurements, characterized in that said device comprises a NO sensor (11), an inlet (1) through which a patient exhales at a predetermined flow rate and pressure, a buffer chamber (7) for temporarily storing a portion of the exhaled air, and means (10) for feeding said portion of the sample to said NO sensor at a flow rate suitable for said sensor.
2. Device according to claim 1, wherein the device comprises a flow regulator (6) for controlling the exhalation flow.
3. Device according to claim 1, wherein the means (10) for feeding said portion of the sample to said NO sensor operates to create a steady flow of about 0.5 to 10 ml/s during a time period longer than the duration of the exhalation.
4. Device according to claim 1, wherein the device comprises means(12)for equalizing the humidity of the sample.
5. Device according to claim 4, wherein said means for equalizing the humidity of the sample consist of a length of tube, made from a catalytic membrane material.
6. Device according to claim 1, wherein the device comprises means for verifying the parameters of the inhalation and controlling the parameters of exhalation.
7. Device according to claim 6, wherein said means comprise a pressure sensor (2) and means for giving feedback to the patient.
8. Device according to claim 6, wherein said means further comprise a flow sensor and means for controlling the flow and/or giving feedback to the patient.
9. Device according to claim 6, wherein said means further comprise a pressure sensor (2) capable of measuring absolute pressure in order to make it possible to compensate for varying partial pressure of NO depending on variations in ambient pressure.
10. Device according to claim 1, wherein the buffer chamber (7) is a maze.
11. Device according to claim 1, wherein the buffer chamber (7) consists of a cylinder with a movable piston.
12. Device according to claim 1, wherein the buffer chamber (7) consists of a length of tube.
13. Device according to claim 1, wherein the device comprises a NO-scrubber through which a patient inhales directly prior to exhaling into the device, thus ensuring that the dead space of the respiratory tract of the patient is filled with NO-free air.
14. Device according to claim 1, wherein the device further comprises an interface for receiving a smartcard on which data linked to a specific user can be stored, and onto which measurement data can be recorded.
15. Device according to claim 14, wherein the device is capable of adapting to different users or different user groups, based on the data stored on the smartcard.
16. Device according to claim 1, wherein said NO sensor is an electrochemical sensor.
17. Device according to claim 1, wherein the sample flow rate when led to the sensor is lower than the exhalation flow rate.
18. A smartcard suitable for use in a device according to claim 1, said smartcard carrying data concerning an individual patient or patient group, wherein at least the following data are recorded on said smartcard - date and time of measurement - measured FE No - sensor ID No - device ID No
19. Method for diagnostic NO measurements using a device comprising a NO sensor, characterized in that:
- a patient exhales into said device, - the exhalation flow rate and pressure is controlled to at least one preset value, respectively, - a sample of the exhalation air is temporarily stored in a buffer chamber, - said sample is fed to said electrochemical NO sensor at a flow rate suitable for said sensor, and - the NO concentration is determined in said sample.
20. Method according to claim 19, wherein the patient inhales NO-free air prior to exhaling into the device.
21. Method according to claim 19, wherein the patient inhales through a NO-scrubber integrated in said device, supplying NO-free air to the patient, prior to exhaling into the device.
22. Method according to claim 19, wherein the patient is given audible or visual feedback during the inhalation and exhalation steps, in order to support the correct performance of said steps.
23. Method according to claim 19, wherein the exhalation flow rate is controlled to a value of about 20 to 800 ml/s and the rate at which the sample is fed to the sensor is about 0.5 to 10 ml/s.
24. Method according to claim 19, wherein said NO sensor is an electrochemical sensor.
25. Method according to claim 19, wherein the sample flow rate when led to the sensor is lower than the exhalation flow rate.
26. A method according to any one of claims 19 - 25, wherein at least one of the following steps is included:
- the patient enters information relating to his/her intake of a medicament - the patient subjectively assesses his/her state of health and enters corresponding information.
27. A computer program comprising the instructions for performing the method according to any one of the claims 19 through 25.
28. A computer program according to claim 27, when stored on a medium.
29. Method for the diagnostic determination on NO in a gas sample, where the parameters governing the taking of the sample are different from the parameters optimal for the accuracy of the NO measurement, characterized in that a device according to any one of claim 1 - 17 is used.
CA2495678A 2002-09-16 2003-09-11 Apparatus and method for diagnostic gas analysis Expired - Lifetime CA2495678C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
SE0202742A SE0202742D0 (en) 2002-09-16 2002-09-16 Apparatus and method for diagnostic gas analysis
SE0202742-3 2002-09-16
SE0202906A SE0202906D0 (en) 2002-10-02 2002-10-02 Apparatus and method for diagnostic gas analysis
SE0202906-4 2002-10-02
PCT/SE2003/001420 WO2004023997A1 (en) 2002-09-16 2003-09-11 Apparatus and method for diagnostic gas analysis

Publications (2)

Publication Number Publication Date
CA2495678A1 true CA2495678A1 (en) 2004-03-25
CA2495678C CA2495678C (en) 2011-12-06

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CA2495678A Expired - Lifetime CA2495678C (en) 2002-09-16 2003-09-11 Apparatus and method for diagnostic gas analysis

Country Status (11)

Country Link
US (4) US7846739B2 (en)
EP (2) EP1661514B1 (en)
JP (1) JP4472533B2 (en)
CN (2) CN102188247B (en)
AT (2) ATE401825T1 (en)
AU (1) AU2003259001B2 (en)
CA (1) CA2495678C (en)
DE (3) DE60322446D1 (en)
ES (2) ES2311264T3 (en)
HK (1) HK1083999A1 (en)
WO (1) WO2004023997A1 (en)

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